Manager, Quality Systems Clinical Laboratory (#0149)Singulex

THIS JOB HAS EXPIRED

Category: Quality Assurance

Summary
The Manager, Quality Systems is responsible for the operation of the laboratory in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Laboratory Practices (GLPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), New York State and California State Laboratory regulations and applicable company policies, procedures and quality initiatives. The Quality Systems Manager performs quality assurance activities of the laboratory by performing the following duties personally or through subordinate supervisors.

Description
Essential Duties and Responsibilities:

Establish and maintain an effective laboratory quality system to ensure that quality assurance standards and regulatory requirements are met.
Establish and maintain a Quality Assurance program that sets process standards, monitors adherence to those criteria, allows assessment of the process, and reports outcomes.
Responsible for the coordination of all laboratory activities to ensure compliance with the laboratory and corporate Quality Systems.
Immediately communicates concerns identified in the testing process to the Sr. Director Laboratory Operations and VP Regulatory & Quality to ensure that questionable test results are not released.
Reviews testing, quality control, lab records and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met.
Participates in audits of manufacturing and laboratory operations, documents audit findings and reports results to Sr. Director Laboratory Operations and VP Regulatory & Quality.
Assists with hosting/coordinating CLIA, OSHA, CAP, New York State, California State and other inspections, as necessary.
Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system regulations and standards in order to effectively perform laboratory quality assurance functions.
Accepts primary responsibility for laboratory procedure development, implementation and training as necessary.
Reviews, tracks and communicates information regarding process variations and quality control samples as required by laboratory quality assurance procedures.
Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
Participates in quarterly management review meetings of the laboratory quality system.
Knowledgeable and experienced in Good Laboratory Practice (GLP) guidelines and Good Clinical Practices as recognized by the FDA in Title 21, Parts 11, 50, 54, 56, 312, 314 and the ICH Guidelines.
Demonstrates a high degree of professional judgment with issues related to the technical, procedural and personnel aspects of the designated area.
Demonstrates exemplary attendance, reliability and skill with interpersonal relationships with all company staff and clients.
Possesses excellent oral and written communication skills.
Adheres to Singulex Health & Safety Guidelines: Singulex has established Health and Safety guidelines for the personal protection of each individual working in the laboratory. Training is provided annually and review is provided as need during staff and team meetings. Strict adherence to the guidelines is required.
Communications: Demonstrates good judgment in the proper mode of communications in group and individual situations. Adapts style to fit the audience and their reaction.
Creativity and Innovation: Contributes to delivering the solution. Identifies opportunities for improvement.
Flexibility: Adapts and is able to work in a changing environment. Produces high quality work product under pressure and within deadlines.
Flexibility: Adapts and is able to work in a changing environment. Produces high quality work product under pressure and within deadlines.
Qualifications
BS/BA in a science field with 5-7 years of experience in quality control or quality assurance in a clinical laboratory, medical device or pharmaceutical manufacturing environment.
Experience maintaining a quality system, with moderate or high complexity testing, according to the CLIA regulations, California laboratory regulations, CAP and NY State laboratory regulations.
Experience maintaining a quality system according to 21 CFR 820 and/or ISO 13485.
Must be proactive and have excellent communication and presentation skills.
Knowledge of cGLP and cGMP regulations is required.
Experience with managing, monitoring and reporting quality data using statistical analysis tools.
Excellent cross-functional team participation skills.
Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communication.
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
Ability to inculcate the Singulex ?Top-5? core values and serve as positive example to team members and others within the organization.
Effective personal communication skills, shares knowledge with excellent training skills.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work with minimal supervision as a member of a team.
Commitment to quality.
Enthusiasm, attention to detail, the ability to meet aggressive deadlines, ability to think ?out of the box,? and ability to work effectively with others in a fast paced, highly-productive environment.